Status:
TERMINATED
CAR-T Cells Therapy in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Zhujiang Hospital
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
The Third Affiliated Hospital of Southern Medical University
Conditions:
Relapsed/Refractory Multiple Myeloma(MM)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.Chimeric ...
Detailed Description
Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways. In rece...
Eligibility Criteria
Inclusion
- Relapsed/Refractory MM patients
- Cell phenotype is BCMA/CD138/CD38/CD56 positive (single or combined) ,and minimal residual disease (MRD) was positive(cytology, genetic testing)
- Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky performance status(KPS) score is more than 60.
- No cytapheresis and cell separation contraindication.
- Hemoglobin is more than 80 gram per litre.
- The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%（EF≥50%）, and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%（SpO2≥90%）;(3)Creatinine（Cr） is less than 2.5 times normal range;(4)Alanine transaminase（ALT） and glutamic-oxalacetic transaminase（AST）is less than 3 times normal range,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL).
- After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk.
- Volunteered for this clinical trail and signed a consent form .
Exclusion
- Patients with high tumor burden or progression of disease need to control the progression of disease in order to decrease the tumor burden.
- Patients with active infection and fever.
- Patients' neutrophilic granulocyte has decreased more than 10 days,and is difficult to control after treatment.
- Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment.
- Patients with infection of HIV or with actively infection of Hepatitis B Virus(HBV) or Hepatitis C Virus(HCV).
- Pregnant or lactating women.
- Patients with severe insufficient cardiac, pulmonary and hepatorenal functions.
- Patients had been treated with cell therapy but was invalid.After analyzing the patient's condition , the expert group think that the patient doesn't fit to attend the therapy of CART.
- The monoclonal antibodies of BCMA or CD38 are invalid for the patients who have used the drug.
- Any situation may do harm to the subjects or interfere the results.
- After allogeneic transplantation, patients are more than 3 degrees of acute Graft-Versus-Host disease(GVHD).
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03473496
Start Date
March 1 2018
End Date
January 31 2020
Last Update
March 15 2024
Active Locations (1)
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1
Southern Medical University Zhujiang Hospital
Guangdong, Guangdong, China, 510000